A Phase II Trial of Evaluation of Acute Toxicity in Hypofractionation With Simultaneous Integrated Boost for Early Breast Cancer
Overview
- Phase
- Not Applicable
- Intervention
- Hypofractionation with simultaneous integrated boost
- Conditions
- Breast Cancer
- Sponsor
- Capital Medical University
- Enrollment
- 35
- Locations
- 1
- Primary Endpoint
- Acute Toxicity
- Status
- Completed
- Last Updated
- 3 months ago
Overview
Brief Summary
Simultaneous integrated boost radiotherapy has been investigated in some malignant tumors and appears to be safe and feasible. However, Hypofractionation with simultaneous integrated boost has been investigating in breast cancer.
Investigators initiated this phase II prospective trial to analyse acute toxicity of hypofractionation with simultaneous integrated boost in patients with early breast cancer.
Detailed Description
Hypofractionated radiotherapy of the breast 15 × 2.70 Gy with simultaneous integrated boost to the tumor bed (total dose within the boost volume 15 × 3.20 Gy)
Investigators
Wenjie Ni
Capital Medical University
Capital Medical University
Eligibility Criteria
Inclusion Criteria
- •Histopathologically confirmed breast cancer operated by breast conserving surgery with clear margins
- •Indication to adjuvant radiotherapy including boost radiotherapy
- •Clearly identified primary tumor region preferably by radiopaque clips
- •Primary wound healing after breast conserving therapy without signs of infection
- •Pre- and/or postoperative chemotherapy and endocrine therapy were permitted when indicated
- •Written informed consent
Exclusion Criteria
- •Patients operated by mastectomy
- •No indication for boost radiation
- •Resection margins positive for disease or insufficient identification of the boost volume
- •Indication for radiotherapy of the regional lymph nodes
- •History of prior breast or thoracic radiotherapy
- •Extended postoperative seroma at the beginning of radiotherapy
- •Psychiatric disorders or psychological disabilities thought to adversely affect treatment compliance
- •Pregnant or lactating patients and woman of child bearing potential, who lacked effective contraception
Arms & Interventions
Hypofractionation with SIB
Hypofractionation with SIB
Intervention: Hypofractionation with simultaneous integrated boost
Outcomes
Primary Outcomes
Acute Toxicity
Time Frame: 6 months
Acute skin radiogenic toxicity grade II or higher according to NCI-CTCAE
Secondary Outcomes
- Feasibility of the radiation plan(19 days)
- other acute Toxicity(0-6 months)